MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA CP
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella cp was returned for evaluation.There were no abnormalities found, and no kinks on the cannula or pigtail were detected.According to the clinical case the physician noted the patient had fragile tissue at the apex, and the patient had an apex infarction in the past.The root cause of the ventricle perforation is likely related to patient condition.
Event or Problem Description
An impella cp was placed for support for hrpci into a (b)(6) old female patient on (b)(6).After the stent was placed echo revealed bleeding in the pericardium.The patient was brought to the or where 400 units of blood was removed, and a perforation of the left ventricle was discovered.The origin of the perforation is unknown.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7395628
• Report Number: 1220648-2018-00018
• Device Sequence Number: 70232
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P1400003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0026
• Device Lot Number: 1322666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR